Placenta Accreta, Third TrimesterNCT03947047
Detection of Placenta Accreta Via Exhaled Women Breath
An observational study of Placenta Accreta, Third Trimester, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Placenta accreta is a relatively rare event, in which the placenta is abnormally implanted into the uterine myometrium. The most significant complication is intense bleeding, mainly during labor. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Placenta Accreta, Third Trimester
- What is being tested?
- NA-NOSE
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 6 Aug 2019to Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women, 28 weeks of gestation or more, with known risk factors for placenta accreta referred to our institute to perform an ultrasound scan for detecting abnormal placentation.
Who may be able to join
- Pregnancy > 28 weeks of gestation.
- Agreement to participate and sign an informed consent.
- Ability to give breath and blood samples.
- Risk factors for placenta accreta:
- Placenta previa.
- Previous 1 or more cesarean sections with placenta in the scar area.
Show all 9Show fewer
- Previous uterine procedures (myomectomy, curretage) and sonographic suspicion of abnormal placentation.
- Exclusion Criteria: None
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
HaEmek Medical Center
Afula, 18101
Raed Salim, MD, 97246494031, salim_ra@clalit.org.il
About this study
Official title: Detection of Placenta Accreta by Means of Volatile Organic Compounds in Exhaled Women Breath. A Prospective Case Control Study.
Placenta accreta is a relatively rare event, in which the placenta is abnormally implanted into the uterine myometrium. The most significant complication is intense bleeding, mainly during labor. The incidence of placenta accreta increased during the last years due to the increase in cesarean delivery rate, which is the main risk factor. Pre-cesarean diagnosis of placenta accreta may improve surgical outcome. Early diagnosis allows appropriate preparation of multidisciplinary team (including, among others; OB-GYN, urologists, anesthesiologists, neonatologists) and massive blood products. Pre-cesarean diagnosis is based on imaging, mainly ultra-sound. This modality has significant false positive rate which may result in extreme sources investment and even indicated pre-term labor, in vain. Volatolome is a complex of volatile markers emitted in several processes in the human body and collected from breath, skin, urine, blood, feces and more. This profile may be used to identify volatile markers for specific medical conditions. NA-NOSE is an electronic device knowing to identify differences in the Volatolome between "healthy" and "sick" subjects. The objective of this study is to identify specific volatile profile for placenta accreta which will help to distinguish between women with placenta accreta and those without.
Read the detailed description
Pregnant women with clinical risk factors for placenta accreta will perform targeted sonographic evaluation for detection of placenta accreta features, according to a standard protocol. Of those with clinical and sonographic risk factors who will agree to participate in the study, will be asked to breathe through a collection device (NA-NOSE) for "lung wash". The participant will be instructed to inhale through the device and exhale to the ambient air for about 3 minutes. After the lung wash step, the collector will inform the participant that she is about to start filling the collective bags. At the end of a regular breath, after exhaling, the collector will ask the participant to take a deep breath so the full volume of the lungs is filled, and then exhale until both the dead space bag and collection bag are full. After filling the first bag, a second bag will be placed and the participant will be asked to repeat the act. In addition, a venous blood sample of 8-10 ml will be taken from each participant.
The samples will be transferred to the Department of Chemical Engineering and Russell Berrie Nanotechnology Institute, Technion-Israel, Institute of Technology. The samples will be analyzed to determine the nature and composition of the volatile biomarkers in the related breath and blood samples.
In this way, the investigators will identify among women who have clinical and sonographic risk factors for placenta accreta, those biomarkers distinguishing women with placenta accreta (group 1) from those who will not have placenta accreta at birth (group 2).
- Conditions
- Placenta Accreta, Third Trimester
- Being tested
- NA-NOSE
- Keywords
- Exhaled Women Breath, Placenta Accreta, Ultrasound
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NA-NOSEDiagnostic test
Breath and blood samples for distinguishing biomarkers.
| Study group | Role | What they receive |
|---|---|---|
| Placenta Accreta | Women found to have abnormal placentation (any degree of placenta accreta) during the cesarean section. Receives: Diagnostic Test: NA-NOSE | |
| No Placenta Accreta | Women found to have normal placenta separation during the cesarean section. Receives: Diagnostic Test: NA-NOSE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of placenta accreta
The aim of the study is to improve pre-cesarean detection of placenta accreta using volatile biomarkers appearing in exhaled breath and/or blood samples, using a simple inexpensive tool termed NA-NOSE.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start6 Aug 2019
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta Accreta, Third TrimesterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Responsible party
- Principal investigator, Sivan Easton, HaEmek Medical Center, Israel
- Investigators
- Sivan Easton, MD, Principal investigator, Emek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947047
- Sponsor's protocol ID
- 0021-19-EMC
- Status last verified
- Aug 2019
- First submitted
- 9 May 2019
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Decision regarding IPD sharing, will be taken later.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Placenta Accreta by Means of Volatile Organic Compounds in Exhaled Women Breath. A Prospective Case Control Study.
- ClinicalTrials.gov ID
- NCT03947047
- Acronym / sponsor ID
- 0021-19-EMC
- Conditions
- Placenta Accreta, Third Trimester
- Keywords
- Exhaled Women Breath, Placenta Accreta, Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 13 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Placenta accreta is a relatively rare event, in which the placenta is abnormally implanted into the uterine myometrium. The most significant complication is intense bleeding, mainly during labor. The incidence of placenta accreta increased during the last years due to the increase in cesarean delivery rate, which is the main risk factor. Pre-cesarean diagnosis of placenta accreta may improve surgical outcome. Early diagnosis allows appropriate preparation of multidisciplinary team (including, among others; OB-GYN, urologists, anesthesiologists, neonatologists) and massive blood products. Pre-cesarean diagnosis is based on imaging, mainly ultra-sound. This modality has significant false positive rate which may result in extreme sources investment and even indicated pre-term labor, in vain. Volatolome is a complex of volatile markers emitted in several processes in the human body and collected from breath, skin, urine, blood, feces and more. This profile may be used to identify volatile markers for specific medical conditions. NA-NOSE is an electronic device knowing to identify differences in the Volatolome between "healthy" and "sick" subjects. The objective of this study is to identify specific volatile profile for placenta accreta which will help to distinguish between women with placenta accreta and those without.
Detailed description
Pregnant women with clinical risk factors for placenta accreta will perform targeted sonographic evaluation for detection of placenta accreta features, according to a standard protocol. Of those with clinical and sonographic risk factors who will agree to participate in the study, will be asked to breathe through a collection device (NA-NOSE) for "lung wash". The participant will be instructed to inhale through the device and exhale to the ambient air for about 3 minutes. After the lung wash step, the collector will inform the participant that she is about to start filling the collective bags. At the end of a regular breath, after exhaling, the collector will ask the participant to take a deep breath so the full volume of the lungs is filled, and then exhale until both the dead space bag and collection bag are full. After filling the first bag, a second bag will be placed and the participant will be asked to repeat the act. In addition, a venous blood sample of 8-10 ml will be taken from each participant.
The samples will be transferred to the Department of Chemical Engineering and Russell Berrie Nanotechnology Institute, Technion-Israel, Institute of Technology. The samples will be analyzed to determine the nature and composition of the volatile biomarkers in the related breath and blood samples.
In this way, the investigators will identify among women who have clinical and sonographic risk factors for placenta accreta, those biomarkers distinguishing women with placenta accreta (group 1) from those who will not have placenta accreta at birth (group 2).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placenta Accreta | – | Diagnostic Test: NA-NOSEWomen found to have abnormal placentation (any degree of placenta accreta) during the cesarean section. |
| No Placenta Accreta | – | Diagnostic Test: NA-NOSEWomen found to have normal placenta separation during the cesarean section. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women, 28 weeks of gestation or more, with known risk factors for placenta accreta referred to our institute to perform an ultrasound scan for detecting abnormal placentation.
Key inclusion criteria (9 listed)
- Pregnancy > 28 weeks of gestation.
- Agreement to participate and sign an informed consent.
- Ability to give breath and blood samples.
- Risk factors for placenta accreta:
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NA-NOSEBreath and blood samples for distinguishing biomarkers. | Diagnostic test | No Placenta Accreta, Placenta Accreta |
Primary outcome
Detection of placenta accreta
Time frame: 2 years
The aim of the study is to improve pre-cesarean detection of placenta accreta using volatile biomarkers appearing in exhaled breath and/or blood samples, using a simple inexpensive tool termed NA-NOSE.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Individual participant dataSharing planned: Undecided. Decision regarding IPD sharing, will be taken later.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sivan Easton, MD principal investigator
Emek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Accreta, Third Trimester, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raed Salim, MD (+972-4-6494030, salim_ra@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of placenta accreta (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.